NC TREK NEO™ 1400325-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648232589), received between Nov 22, 2022 and Jan 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, AND 90% STENOSED DISTAL LEFT CIRCUMFLEX ARTERY. AN NC TREK 3.25X15MM WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12ATM. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24216488 ↗
• MalfunctionSep 15, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.25X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE WITH THE ANATOMY. HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATMS. THEREFORE, THE BDC WAS REPLACED WITH A NEW NC TREK BDC AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058679 ↗
• MalfunctionDec 13, 2023Device Damaged by Another Device; Difficult to Advance; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SHORT LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE VERSATURN GUIDE WIRE WAS ADVANCED. PRE-DILATATION WAS PERFORMED USING A 2.5X12 TREK RX BALLOON DILATATION CATHETER (BDC) FOLLOWED WITH THE FIRST OPTICAL COHERENCE TOMOGRAPHY (OCT) RUN IN THE LAD. THE 3.25X28MMMM XIENCE SKYPOINT STENT WAS THEN IMPLANTED. THE 3.25X15MM NC TREK NEO BDC WAS USED FOR POST DILATATION, HOWEVER, THERE WAS RESISTANCE FELT AT THE PROXIMAL EDGE OF THE XIENCE SKYPOINT STENT, DUE TO THE BDC NOT BEING ABLE TO BEND THE CURVE OF THE VESSEL AND AFTER PUSHING SLIGHTLY WAS ABLE TO ADVANCE TO THE DISTAL PORTION OF THE STENT AND DILATATION WAS PERFORMED WITHOUT ISSUES. ANOTHER OCT RUN WAS PERFORMED TO CHECK THE PLACEMENT OF THE STENT AND UPON EVALUATION OF THE OCT IMAGE, IT WAS NOTED THAT THERE WAS SIGNIFICANT MALAPPOSITION OF THE STENT AND AN ABSENCE OF STENT STRUTS ON THE OPPOSING WALL WHICH WAS CONFIRMED IN THE LONGITUDINAL MODE DISPLAY DEMONSTRATING THAT 2 OF THE PROXIMAL STENT STRUTS WERE PROLAPSED ON ONE ANOTHER. THE OPPOSING WALL OF THE STENT HAD LIFTED FROM THE WALL CAUSING A >300 MICRON MALAPPOSITION. THE PHYSICIAN THEN DECIDED TO INFLATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319327 ↗
• MalfunctionJan 6, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN THE LEFT MAIN CORONARY ARTERY (LM OR LMCA) TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.25X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, IT MET HEAVY RESISTANCE INSIDE OF THE GUIDE CATHETER (GC) AND COULD NOT BE FULLY ADVANCED OUT OF THE GC. THE BDC WAS DIFFICULT TO REMOVE FROM THE GUIDE CATHETER BUT WAS ULTIMATELY REMOVED, AND ANOTHER NC TREK NEO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114196 ↗
• MalfunctionNov 22, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE LEFT MAIN ARTERY TO THE LEFT ANTERIOR ARTERY. POST STENT IMPLANTATION, A 3.50X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) AND A 3.25X15MM NC TREK NEO BDC WERE ATTEMPTED TO BE ADVANCED TO THE TARGET LESION FOR POST DILATION USING THE KISSING BALLOON TECHNIQUE. HOWEVER, THE BALLOON DILATATION CATHETERS MET WITH DIFFICULTY WHEN ADVANCING INSIDE THE GUIDE CATHETER. THEREFORE, THE BDCS WERE REMOVED FROM THE PATIENT AND DIFFICULTY WAS ALSO NOTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. THE PROCEDURE WAS CONTINUED WITH 2 NON-ABBOTT BALLOONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849462 ↗